Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

Sponsor
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Study ID
NCT06114004
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sarcoma,Soft Tissue

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor 20 MG — DRUG
    After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor
  • Gemcitabine — DRUG
    Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days.

Study Details

Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial. Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.

Key Dates

Start date
Sep 28, 2023
Status verified
Oct 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: gemcitabine + selinexor:
    Selinexor will be given at 60 mg once per week orally days 1, 8 and 15 every 21 days Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days

Primary Outcome Measure

progression-free survival rate (PFSR) [ Time Frame: 6 months ]

Central Contacts

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